Caring for carers of people with Parkinson's disease

Caring for carers of people with Parkinson's disease (C4C-PD): a multicentre randomised controlled trial of the development and evaluation of a nurse-led group-based psychological intervention for caregiver stress and distress

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21346995

Enrollment

146

Registered

2009-07-21

Start date

2009-08-01

Completion date

Unknown

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carer stress

Interventions

1. Cognitive behavioural therapy nurse-led group intervention: 6 - 9 carers per group, 8 x 2 hour sessions at weekly intervals over 2 - 3 months. Intervention guided by trial manual and supporting mat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must: 1. Be the primary caregiver for the person with Parkinson's disease and either live in the same home and/or have at least 12 hours direct care-related contact per week 2. Be able to provide informed consent 3. Be willing and able to attend 8 weekly or fortnightly sessions 4. Score 5 or more ('case' level problems) using binary (0/1) scoring on the 28-item General Health Questionnaire (GHQ-28) 5. Be aged 18 years or older (no upper age limit), males or females

Exclusion criteria

Exclusion criteria: Participants will be excluded if they: 1. Lack sufficient spoken language skills and literacy to meaningfully engage with the sessions or complete treatment related activities between sessions 2. Are felt unlikely to comply with the 'rules' that typically apply to participants in group-based interventions (e.g. maintaining confidentiality, allowing others to speak) 3. They have received psychological therapy or a course of counselling in the past year, are currently receiving treatment or counselling, or plan to start in the next year

Design outcomes

Primary

Measure	Time frame
28-item General Health Questionnaire (GHQ-28): score at the end of treatment for the immediate treatment group compared to score of the delayed treatment group at the same timepoint. Measured at pre-randomisation and end of treatment (for active arm) or at 3 months (for control arm). All will be assessed again at 3 months post-treatment to assess uncontrolled delayed effects.	—

Secondary

Measure	Time frame
1. Zarit Caregiver Burden Interview 2. Caregiver Strain Index 3. Geriatric Depression Scale (GDS-15) In addition to the analysis at the primary endpoint, (uncontrolled) treatment effects at the end of follow-up relative to baseline and end of treatment will be analysed as a secondary endpoint. All measured at pre-randomisation and end of treatment (for active arm) or at 3 months (for control arm). All will be assessed again at 3 months post-treatment to assess uncontrolled delayed effects.	—

Measure

Time frame

1. Zarit Caregiver Burden Interview 2. Caregiver Strain Index 3. Geriatric Depression Scale (GDS-15) In addition to the analysis at the primary endpoint, (uncontrolled) treatment effects at the end of follow-up relative to baseline and end of treatment will be analysed as a secondary endpoint. All measured at pre-randomisation and end of treatment (for active arm) or at 3 months (for control arm). All will be assessed again at 3 months post-treatment to assess uncontrolled delayed effects.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026